A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]E7090

Study type: Interventional

Funder types: Industry

Identifiers

NCT04493255

2019-004957-10 (EudraCT Number)

E7090-E044-002

Details and patient eligibility

About

The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.

Enrollment: 8 patients

Sex: Male

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Non-smoking, healthy males, age greater than or equal to (>=) 35 years and less than or equal to (<=) 55 years old at the time of informed consent
2. Body Mass Index (BMI) of >=18 to <=32 kilogram per square meter (kg/m^2) at Screening
3. Provide written informed consent
4. Willing and able to comply with all aspects of the protocol
5. History of a minimum of 1 bowel movement per day

Exclusion criteria

1. Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)

2. Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090

3. Participant has had exposure to significant diagnostic or therapeutic radiation (example: serial x-ray, computed tomography scan, barium meal) or has current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1

4. Participant has the following ocular disorders:

   1. Any previous history or current evidence of corneal disorder
   2. Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)

5. Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)

6. Participants has a known history of food allergies or significant seasonal or perennial allergy

7. Participants is known to be human immunodeficiency virus positive at Screening

8. Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening

9. Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)

10. Participant received blood products within 2 months prior to Day -1, or donation of blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to Screening, or donation of platelets from 6 weeks prior to Screening

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

E7090

Experimental group

Description:

Participants will receive 100 microcurie (μCi) of \[14C\]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.

Treatment:

Drug: [14C]E7090